000			04481nam a22006497a 4500
005			20240807190551.0
008			240807s20242024 xxu||||| |||| 00| 0 eng d
022			_a1878-0938
024			_aS1553-8389(24)00580-3 [pii]
040			_aOvid MEDLINE(R) _cwhc
099			_a39013705
245			_aHigh-risk percutaneous coronary intervention with or without mechanical circulatory support: Will Impella show superiority in the PROTECT IV randomized trial?.
251			_aCardiovascular Revascularization Medicine. 2024 Jul 14
252			_aCardiovasc Revasc Med. 2024 Jul 14
253			_aCardiovascular revascularization medicine : including molecular interventions
260			_c2024
260			_fFY2025
260			_p2024 Jul 14
265			_saheadofprint
265			_tPublisher
266			_d2024-08-07
266			_z2024/07/16 21:58
501			_aAvailable in print through MWHC library: 2002 - present
520			_aBACKGROUND: PROTECT IV is a current enrolling randomized controlled trial evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered.
520			_aCONCLUSION: Therefore, PROTECT IV estimates that a sample size of 1252 patients is required for Impella to be declared superior to the non-Impella group. Using our observed 2-year outcome of 30.8 %, we estimate that PROTECT IV requires 1966 patients, demonstrating that PROTECT IV is probably underpowered. Copyright © 2024 Elsevier Inc. All rights reserved.
520			_aMETHODS AND RESULTS: A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis. The composite rates of all-cause death, MI, target lesion revascularization, and target vessel revascularization at 1, 2, and 3 years were estimated using the Kaplan-Meier method, and the results were used to calculate the sample size under the constant hazard ratio assumption and expected number of events to be observed used in planning PROTECT IV. The primary endpoint occurred in 30.8 % of patients at 2 years. PROTECT IV assumes a hazard ratio of 0.75 using a multivariate Cox regression, which, under a 5 % level and 90 % power, yields 516 events. This implies a 2-year primary outcome rate of 50 % for the non-Impella arm.
546			_aEnglish
650			_aIN PROCESS -- NOT YET INDEXED
650			_zAutomated
651			_aMedStar Heart & Vascular Institute
651			_aMedStar Washington Hospital Center
656			_aAdvanced Cardiac Catheterization Research Fellowship
656			_aCardiovascular Disease Fellowship
656			_aInterventional Cardiology Fellowship
657			_aJournal Article
700			_aAbusnina, Waiel _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dMBBCh
700			_aAhmed, Shaan _bMWHC _cCardiovascular Disease Fellowship _dMD
700			_aBanerjee, Avantika _bMHVI
700			_aBen-Dor, Itsik _bMHVI
700			_aBernardo, Nelson L _bMHVI
700			_aCase, Brian C _bMHVI
700			_aChaturvedi, Abhishek _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dMBBS
700			_aChitturi, Kalyan _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dDO
700			_aHaberman, Dan _bMWHC _cInterventional Cardiology Fellowship _dMD
700			_aHashim, Hayder _bMHVI
700			_aLupu, Lior _bMWHC _cInterventional Cardiology Fellowship _dMBA, MD
700			_aMerdler, Ilan _bMHVI
700			_aReddy, Pavan _bMWHC _cAdvanced Cardiac Catheterization Research Fellowship _dMD
700			_aRogers, Toby _bMHVI
700			_aSatler, Lowell F _bMHVI
700			_aSawant, Vaishnavi _bMHVI
700			_aWaksman, Ron _bMHVI
700			_aZhang, Cheng _bMHVI
790			_aChitturi KR, Zhang C, Abusnina W, Sawant V, Banerjee A, Ahmed S, Merdler I, Haberman D, Chaturvedi A, Lupu L, Reddy P, Case BC, Rogers T, Hashim HD, Ben-Dor I, Bernardo NL, Satler LF, Waksman R
856			_uhttps://dx.doi.org/10.1016/j.carrev.2024.07.003 _zhttps://dx.doi.org/10.1016/j.carrev.2024.07.003
942			_cART _dArticle _2ddc
999			_c14349 _d14349